Effects of Thoracic Erector Spinae Plane Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS)

NCT04208542 | Unknown Phase 4 DMC

• 1 other identifier: 4-2019-0050
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized study intended to assess the efficacy of erector spinae plane analgesia on acute and chronic postoperative pain for VATS procedures. It will include 72 patients presenting to Severance hospital for a VATS procedure. Patients will be randomized 1:1 to receive either ESP block and intravenous patient-controlled analgesia (IV PCA) or IV PCA only. Ropivacaine will be used in nerve block, and injected at the end of surgery. The primary outcome will be to compare analgesic efficacy between the two groups as defined by immediate postoperative pain scores on the numeric pain rating scale. Secondary outcomes include total opioid consumption, painDETECT score, and chronic pain scores.

Conditions

Thoracic

Keywords

Thoracic surgical procedures

Outcome Measures

Primary Outcomes (1)

• Numeric rating scale (NRS)

  These scores will record till the postoperative 48 hours. \- The Numerical Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

  up to postoperative 48 hours.

Secondary Outcomes (4)

• opioid consumption

  postoperative 48th hours

• opioid consumption

  3 months after surgery.

• postoperative painDETECT score

  up to postoperative 3 months.

• NRS

  up to postoperative 3 months.

Study Arms (2)

Interventional

ACTIVE COMPARATOR

Under general anaesthesia, ultrasound guided ESP block will perform at the T5 level with 0.375% ropivacaine 20ml. Fentanyl 1 ug/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with fentanyl (10 ug/kg) and palonosetron 0.075mg will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 48 hours. Pain assessment will record 3 months after surgery.

Drug: ESP block

Control

NO INTERVENTION

Fentanyl 1 ug/kg will administer at last 30 minutes of surgery for postoperative analgesia. Patient controlled analgesia (PCA) with fentanyl (10 ug/kg) and palonosetron 0.075mg will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 48 hours. Pain assessment will record 3 months after surgery.

Interventions

ESP block DRUG

Ultrasound guided Erector spinae block (ESP) will perform.

Interventional

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female participants providing written informed consent,
• ASA grade 1-3,
• aged over 20 and under 80,
• primary lung cancer participants scheduled segmentectomy or lobectomy c MLND,
• undergoing a VATS procedure under General Anaesthesia

You may not qualify if:

• Absence of informed written consent,
• chemotherapy before or after surgery,
• pre existing infection at block site,
• severe coagulopathy,
• pre existing neurological deficit,
• previous history of opiate abuse,
• pregnancy,
• pre existing chronic pain condition,

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

Central Study Contacts

Sang Jun Park

CONTACT

82-2-2228-2405; iotas@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Both participants and anesthesia provider will not know which intervention applied. Another anesthesia provider who did not perform nerve block will follow and record to the study data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 groups of patients will be studied simultaneously. One group will have the intervention of the ESP block and IV PCA. The other group will have only IV PCA.

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 23, 2019
• Study Start: April 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

KR (1)